Your obligations 2013-2018

1. Access and publication

The Consortium Agreement and IMI Intellectual Property Policy regulate access rights for all consortium partners and Target Contributing Third Parties during completion of the project and subsequent research use and/or direct exploitation. As a Target Contributing Third Party, you grant non-exclusive royalty-free access rights to the Background you have on the Target Programme to the partners within the European Screening Centre necessary for them to perform the work on your Target Programme. After expiration of the three-year exclusivity period, the following information of your QHL/IHL will be made available within the consortium via the Programme office (Lygature, formerly TI Pharma): Programme Name, target, gene ID and mechanism of action. This information will be shared with the other consortium partners, however, your party name will not be disclosed. If another Partner is interested in obtaining research use rights for your Target Programme, such rights should be negotiated on Fair and Reasonable conditions in accordance with the Consortium agreement.

The results of the Target Programme have to be disseminated to the public in accordance with the timelines in the Consortium agreement (in general 1 year after the end of the project). However, this does not oblige you to publish each and every data point of the work that has been done. Publication of scientific results is subject to a defined Publication Policy and related approval process, designed to protect confidential information and limit potential conflicts with consortium partners. Review and possible IP protection measures may delay submission for publication by a maximum of 45 plus 90 days, respectively. In addition, if there is an interest by an EFPIA Participant to negotiate for a license of the results for direct exploitation, there could be an additional 180 day delay.

2. Payments

Hit discovery and characterization are based on collaboration between you and the EU Lead Factory. On disclosure of the QHL/IHL to you, ownership of the results is transferred to you.In the case of direct exploitation of your Programme, you agree to compensate the Party that has provided the relevant compound on your QHL via a scheme of milestone payments. These are triggered by defined events along the value chain, starting with patent filing (more specifically the PCT application), and require patent claims to include either a QHL/IHL compound or derivative.A flexible payment schedule is provided, but the option for payment of the Patent milestone must be selected at the time the Target Programme is accepted. The list of milestone payments is the following for a pharmaceutical product:

• one of 3 patent milestone options: €50.000 with PCT filing, €75.000 within 2 years from filing, or 10% of the compensation your receive based on the Target Programme.
• additional (clinical) milestones including:
  • IND filing: € 250.000
  • start phase II: € 750.000
  • start phase III: € 2.500.000

For a diagnostic product containing a QHL/IHL compound or a derivative, a single clinical milestone of €250.000 is due with market launch in the European Union, the United States of America, China, Brazil, India or Japan.Licensing or transferring your Target Programme to a third party other than an EFPIA Participant of the European Lead Factory will trigger a one-time payment (€250.000 prior to IND filing and €1.000.000 after IND filing). Target Programmes that relate to neglected tropical diseases as defined by the World Health Organization, may be granted the status of a Neglected Disease Target Programme upon selection. The consortium has decided to waive the clinical, diagnostic and ownership milestone payments for these programmes as long as the results will not be commercialized outside the Least Developed Countries. The patent milestone payment regimen remains for these programmes.

3. Option to License

By signing the Form of Accession, you will give EFPIA participants the right to submit a first offer on licensing your Target Programme. This is before publication or licensing to a third party, and at the latest upon expiration of the three-year exclusivity period. The option must include at least a non-exclusive licence on the target of your target programme and all relevant background information, and an exclusive licence on its associated QHL/IHL. If you cannot reach an agreement with any EFPIA Participant, you can then offer your programme to any third party, or you can continue development.